Eisai-Biogen seek full approval for Alzheimer’s drug

March 7, 2023

The U.S. FDA has accepted the supplemental Biologics License Application for Eisai and Biogen's codeveloped Alzheimer’s drug, granting Priority Review for traditional approval.

Leqembi, anti-amyloid beta protofibril antibody, was approved in January under an Accelerated Approval pathway, and the drugmakers announced then that they intended to seek approval under a traditional pathway.  The Accelerated Approval was limited to patients in mild stages of cognitive impairment or dementia.

Leqembi's PDUFA date is now set for July 6, 2023, and the FDA is planning to hold an Advisory Committee meeting to discuss the application. 

The sBLA acceptance was supported by results from the confirmatory Phase trial, Clarity AD, in which all primary and secondary endpoints were met with highly statistically significant results. 

With lessons learned from Aduhelm, Eisai has focused on obtaining payer coverage for Leqembi. But the drugmakers remain confident that the Clarity AD trial has a robust design, which could meet the “high level of evidence” criteria set forth by CMS in the NCD decision memo if the result is positive; therefore, creating the potential for CMS to reconsider full coverage of Leqembi.